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Phenobarbital for Acute Alcohol Withdrawal

Information source: Alameda County Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Withdrawal

Intervention: 10 mg/kg IV phenobarbital in 100 ml saline (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Jonathan Rosenson


Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Clinical Details

Official title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Number of Patients Requiring Continuous Lorazepam Infusion

Percentage of Patients Requiring ICU Admission

Total Lorazepam Required Per Patient Per Admission

Secondary outcome:

Length of Stay

Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability

Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability

Number of Study Patients With Seizure as a Measure of Safety and Tolerability

Number of Study Patients With Mortality as a Measure of Safety and Tolerability


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

- allergy to phenobarbital, lorazepam, age<18 or >65

Locations and Contacts

Alameda County Medical Center, Oakland, California 94608, United States
Additional Information

Starting date: January 2009
Last updated: March 7, 2012

Page last updated: August 23, 2015

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